Global Formulation Development Outsourcing Market is segmented By Service (Pre Formulation Services & Formulation Optimization), By Dosage Forms (Injectable, Oral, Topical, Inhaled & Others), By Application (Oncology, Genetic disorders, Neurology, Infectious diseases, Respiratory diseases & Cardiovascular diseases), By End User (Pharmaceutical and Biopharmaceutical Companies & Government and Academic Institutes), By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030
Formulation Development Outsourcing Market Overview
The Global Formulation Development Outsourcing Market is predicted to reach at a high CAGR during the forecast period (2023-2030).
The demand for outsourcing pharmaceutical formulation development and manufacturing is on the rise for drug developers at all levels. Formulation development is an area of product development that can determine patentability, lifecycle and, ultimately, the success of a pharmaceutical product. Companies integrate formulation development functions and personnel into their product development cycle in many different ways. Outsourcing drug development is a growing trend in the pharmaceutical and biotechnology industries. Outsourcing compresses the timeline of product development and provides a cost-effective alternative to adding specialized resources.
Formulation Development Outsourcing Market SUMMARY AND SCOPE
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Metrics |
Details |
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Market CAGR |
High |
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Segments Covered |
By Service, By Dosage Forms, By Application, By End User, and By Region |
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Report Insights Covered |
Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights. |
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Fastest Growing Region |
Asia Pacific |
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Largest Market Share |
North America |
Formulation Development Outsourcing Market Dynamics and Trends
The patent protection expiration of effective drugs is one factor driving the growth of the formulation development outsourcing market. There has been increasing demand for drugs and medical devices because of the growing population, especially in emerging economies. The market around the globe will expand in the forecast period.
Increasing patent protection expiration will drive the market growth
The growing importance of the innovation of novel drugs because of the increasing patent expiration of major drugs and the increase in the outsourcing of formulation development services by most pharmaceutical and biotechnological companies are significant factors driving the market's growth. Most biopharmaceutical companies partner with outsourcing services in the early phase of drug development to overcome the risk and save time and money in passing the drug through the development phase.
The rising burden of chronic diseases across the globe is driving the market growth
Chronic diseases and conditions are on the rise worldwide. Pharmaceutical and biotechnology industries in Europe invest in R&D in recent years due to the rising demand for advanced medicines. This may be attributed to the increasing aging population, chronic diseases, and infectious diseases.
Formulation development plays a vital role in anti-cancer drugs as formulation includes stability, solubility and bioavailability during the drug development.
Side Effects associated with insufficient funding in the drug development process
Drug development is a lengthy, costly and complex process entrenched with a high degree of uncertainty that a drug will succeed. Funding plays a vital role in every step of the drug development stage. Ultimately, long development times coupled with low success rates translate into high overall R&D costs. Based on recently published Tufts CSDD data, the average capitalized cost to bring one new biopharmaceutical product to market, including the cost of failures, is $1.24 billion in 2005 dollars. For traditional pharmaceutical products, the cost is $1.32 billion.
COVID-19 Impact Analysis on Formulation Development Outsourcing Market
The rapidly growing threat of COVID-19 is impacting lives, communities and industries around the world. Especially during these times, many collaborative research programs are taking initiatives to fast-track in terms of advancing therapeutics, vaccines and medicines to deal with the pandemic.WHO launched a "Solidarity," an international clinical trial to find an effective treatment for COVID-19. WHO expert groups identified four repurposed antiviral drugs that might have at least a moderate effect on mortality: remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a.In March 2020, the WHO began a large, simple, international, open-label, randomized trial involving hospital inpatients to evaluate the effects of these four drugs on in-hospital mortality.
The global COVID-19 pandemic has caused significant disruptions to industries, economies, and life in general. Within the bio/pharma industry, companies have been working at great speeds to help develop solutions to tackle the virus despite the challenging situation. Additionally, outsourcing activity has surged within the industry, primarily driven by the unprecedented demands for research, development, and manufacturing the pandemic is creating.
With the increasing R&D along with clinical trials for the development of therapeutics for COVID-19 treatment, the studied market is to witness significant growth over the pandemic.
Formulation Development Outsourcing Market Segmentation Analysis
Based on services, Formulation Development Outsourcing Market is divided into Pre Formulation Services (Formulation Discovery, Preclinical Services, Analytical Services) and Formulation Optimization (Phase I, Phase II, Phase III, and Phase IV).
The formulation optimization segment dominated the market
Due to the services it provides, such as solubility, Ph profile studies, drug excipient compatibility studies, testing and manufacturing development studies. This segment holds a significant part of the market.
By Dosage Forms, Formulation Development Outsourcing Market is divided into Injectable, Oral, Topical, Inhaled, Infectious diseases
Injectables hold a significant share in the market.
Based on Application, Formulation Development Outsourcing Market is divided into oncology, genetic disorders, neurology, infectious diseases, respiratory, cardiovascular, and others.
The oncology segment is expected to witness significant growth over the forecast period
Due to the rising incidence of cancer cases globally and the active participation of pharmaceutical companies to outsource their services. The FDA approved or added new indications to 47 drugs or biologics for oncology in 2018, and 20 such approvals in oncology have already been made in 2019. The drug-development process that may ultimately result in FDA approval is lengthy and requires many steps to ensure that the product is safe and effective. Formulations play a vital role in anti-cancer drugs as formulation issues, including stability, solubility, and bioavailability, are essential for drug development. Hence many pharmaceutical companies are involved in developing formulations to provide end-to-end solutions.
By End-User, the market is segmented into Pharmaceutical and Biopharmaceutical Companies and Government and Academic Institutes.
The pharmaceutical and biopharmaceutical companies segment is growing
With the rise in demand for outsourcing pharmaceutical formulations, this segment will increase over the forecast period. Increase in the demand for therapeutic formulations and medications for cancer and Covid. This segment is going to gain the most profit in the market.
Formulation Development Outsourcing Market Geographical Share
North America segment holds a significant share in the market
The North American region is expected to witness tremendous growth in the market. With increasing chronic diseases and the presence of key players in this region. And with the highly developed healthcare infrastructure and advanced technological developments in this region.
The United States accounted for 42% of prescription drug spending and 40% of the total GDP among innovator countries and was responsible for developing 43.7% of the NMEs., Many drugs are expected to phase patent expiration in the United States between 2020-2022, which include Chantix and Inlyta (Pfizer, Inc.), Dexilant (Takeda Pharmaceuticals USA Inc), Silenor (Currax Pharmaceuticals LLC), among others. Hence, the growing patent expirations are expected to drive the innovation of novel therapeutics, which boosts the studied market in the North American region.
Formulation Development Outsourcing Companies and Competitive Landscape
The Formulation Development Outsourcing Market is quite competitive. Key players such as Charles River Laboratories, Aizant Drug Research Solutions Private Limited, Catalent, Inc., Laboratory Corporation of America Holdings, Syngene International Ltd., IRISYS, LLC, Intertek Group plc, Piramal Pharma Solutions, Qiotient Sciences, Lonza Group AG and Dr. Reddy's Laboratories Ltd
Major players are adopting many strategic alliances such as collaborations and new product launches to expand their product portfolio and secure a position in the market.
Catalent Inc
Overview: Catalent Inc is a multinational corporation. It is a global dealer of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians. Catalent has agreed to acquire MaSTherCell Global, a company backed by Great Point Partners, SFPI-FPIM, and Orgenesis Inc. (NASDAQ: ORGS), for an aggregate of $315 million in cash, subject to customary adjustments.
Catalent offers comprehensive evaluations of compounds from formulation through preclinical in vivo proof-of-concept and can provide you with preclinical formulations to help you move more molecules from discovery to development.
Product Portfolio: The company's portfolio comprised of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products
Why Purchase the Report?
- Visualize the composition of the Formulation Development Outsourcing Market segmentation by Service, Dosage Forms, Application, and end-user highlighting the key commercial assets and players.
- Identify commercial opportunities in Formulation Development Outsourcing Market by analyzing trends and co-development deals.
- Excel data sheet with thousands of data points of Formulation Development Outsourcing Market- level 4/5 segmentation.
- PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
- Product mapping in excel for the key product of all major market players
The Formulation Development Outsourcing Market report would provide access to an approx. 69 market data table, 65 figures and 180 pages.
Target Audience
- Service Providers/ Buyers
- Industry Investors/Investment Bankers
- Education & Research Institutes
- Research Professionals
- Emerging Companies
- Manufacturers
